Safety and Efficacy of ADC189 in Children 2-11 Years Old With Influenza

A Phase III, Multicenter, Randomized, Double-blind, Controlled Study to Evaluate Pharmacokinetics, Safety and Efficacy of ADC189 Tablets/Granules in Children 2-11 Years Old With Influenza

Currently, there is only one treatment which only need one single oral dose for influenza in children five years above (Baloxavir marboxil) in China. This study will test a medicine for influenza in children younger than 5 year of age to see if it is safe and effective.

This is a multicenter, randomized, double-blind, controlled Phase III clinical study.

The study evaluates the pharmacokinetics, safety and efficacy of ADC189 tablets/granules following a single oral dose in children aged 2 to 11 years with influenza.

Study Overview

• Status: Completed
• Conditions: Influenza Type B; Influenza Type A
• Intervention / Treatment: Drug: ADC189 tablets; Drug: Placebo of Baloxavir Marboxil tablets; Drug: Baloxavir Marboxil tablets; Drug: Placebo of ADC189 tablets; Drug: ADC189 granules; Drug: Placebo of ADC189 granules; Drug: Placebo of Oseltamivir granules; Drug: Oseltamivir granules

• Study Type: Interventional
• Enrollment (Actual): 190
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China
      • Beijing Children's Hospital，Capital Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Key Inclusion Criteria:

• 1. Patients aged 2 to 11 years at screening, both sex;
• 2. Patients were diagnosed with Influenza A Vairus Infection/Influenza B Virus Infection.
• 3. Parents willing and able to comply with study requirements, under the judgment of investigators .
• 4. Onset of symptoms no more than 48 hours before presentation for screening.

Key Exclusion Criteria:

• 1. Patients with severe influenza.
• 2. Pregnant or breast-feeding females
• 3. Patients with acute respiratory infection, tympanitis, sinusitis, or acute asthma attack within 2 weeks before screening.
• 4. Presence of a chronic disease or illness that may indicate increased risk for influenza-related complications.
• 5. Other antiviral therapy is required during screening.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Triple

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ADC189 tablets Group (Part 1); Around 30 patients, 6-11 years old.	Drug: ADC189 tablets; Patients weigh between 20 to 80 kilograms, given 45 mg ADC189 tablets once; patients weigh over 80 kilograms, given 90 mg ADC189 tablets once.; Drug: Placebo of Baloxavir Marboxil tablets; Patients weigh between 20 to 80 kilograms, given 2 tablets of placebo once; patients weigh over 80 kilograms, given 4 tablets of placebo once.
Active Comparator: Baloxavir marboxil tablets Group (Part 1); Around 15 patients, 6-11 years old.	Drug: Baloxavir Marboxil tablets; Patients weigh between 20 to 80 kilograms, given 40 mg Baloxavir marboxil tablets once. Patients weigh over 80 kilograms, given 80 mg Baloxavir marboxil tablets once.; Drug: Placebo of ADC189 tablets; Patients weigh between 20 to 80 kilograms, given 1 tablet of placebo once; patients weigh over 80 kilograms, given 2 tablets of placebo once.
Experimental: ADC189 granules Group (Part 2A); Around 60 patients, 5-11 years old.	Drug: Placebo of Baloxavir Marboxil tablets; Patients weigh between 20 to 80 kilograms, given 2 tablets of placebo once; patients weigh over 80 kilograms, given 4 tablets of placebo once.; Drug: ADC189 granules; For patient 5-11 years old, patients weigh between 20 to 80 kilograms, given 45 mg ADC189 granules once; patients weigh over 80 kilograms, given 90 mg ADC189 granules once. For patient 2-4 years old, patients <10kg, given 15mg ADC189 granules once. 10kg ~ <15kg, given 25mg ADC189 granules once. 15kg ~<20 kg, given 35mg ADC189 granules once. 20kg ~ <80kg, given 45mg ADC189 granules once.
Active Comparator: Baloxavir marboxil tablets (Part 2A); Around 30 patients, 5-11 years old.	Drug: Baloxavir Marboxil tablets; Patients weigh between 20 to 80 kilograms, given 40 mg Baloxavir marboxil tablets once. Patients weigh over 80 kilograms, given 80 mg Baloxavir marboxil tablets once.; Drug: Placebo of ADC189 granules; Placebo. Given once only.
Experimental: ADC189 granules (Part 2B); Around 20 patients, 2-4 years old.	Drug: ADC189 granules; For patient 5-11 years old, patients weigh between 20 to 80 kilograms, given 45 mg ADC189 granules once; patients weigh over 80 kilograms, given 90 mg ADC189 granules once. For patient 2-4 years old, patients <10kg, given 15mg ADC189 granules once. 10kg ~ <15kg, given 25mg ADC189 granules once. 15kg ~<20 kg, given 35mg ADC189 granules once. 20kg ~ <80kg, given 45mg ADC189 granules once.; Drug: Placebo of Oseltamivir granules; For patients 2-4 years old. Placebo. Given 10 times (5 days, BID).
Active Comparator: Oseltamivir granules (Part 2B); Around 10 patients, 2-4 years old.	Drug: Placebo of ADC189 granules; Placebo. Given once only.; Drug: Oseltamivir granules; For patients 2-4 years old. Patients <15kg, given 30mg×10 times (5 days, BID) Oseltamivir granules. 15kg ~ <23kg, given 45mg×10 times (5 days, BID) Oseltamivir granules. 23kg ~ <40kg, given 60mg×10 times (5 days, BID) Oseltamivir granules. ≥40kg, given 75mg×10 times (5 days, BID) Oseltamivir granules.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The safety of study drug, Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)	An AE is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not considered related to the medicinal (investigational) product. A SAE is any significant hazard, contraindication, side effect that is fatal or life-threatening, requires hospitalization or prolongation of an existing hospitalization, results in persistent or significant disability/ incapacity, is a congenital anomaly/ birth defect, is medically significant or requires intervention to prevent one or other of the outcomes listed above.	From Day 1 up to 15 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Plasma Concentrations of ADC189 and ADC189-I07	ADC189-I07 is an active metabolite of ADC189. Four plasma samples were collected in 4 time points from each patient. This data is collected for Pop PK analysis.	From Day 1 up to 14 days, 4 time points.
Time to Resolution of Influenza Symptoms	Subjects or parents or caregivers were asked to provide an assessment of age-appropriate influenza symptoms on a CARIFS Questionare.	From Day 1 up to 14 days

Collaborators and Investigators

• Sponsor: Jiaxing AnDiCon Biotech Co.,Ltd

Study record dates

Study Major Dates

• Study Start (Actual): August 19, 2024
• Primary Completion (Actual): January 27, 2025
• Study Completion (Actual): April 15, 2025

Study Registration Dates

• First Submitted: July 12, 2024
• First Submitted That Met QC Criteria: July 12, 2024
• First Posted (Actual): July 18, 2024

Study Record Updates

• Last Update Posted (Estimated): September 23, 2025
• Last Update Submitted That Met QC Criteria: September 18, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Orthomyxoviridae Infections; Influenza, Human; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Enzyme Inhibitors; baloxavir
• Other Study ID Numbers: ADC189GR-20230808

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No